All Clinical Trials for Metoclopramide Hydrochloride

RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients
treated with chemotherapy. It is not known whether receiving dexamethasone with granisetron
is more effective than receiving dexamethasone with metoclopramide for reducing the side
effects of chemotherapy.
PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with
either granisetron or metoclopramide in patients treated with chemotherapy.

Metoclopramide to Treat Anemia in Patients With Myelodysplastic Syndrome (MDS)

Withdrawn

National Heart, Lung, and Blood Institute (NHLBI)

Phase 2

2005-07-01

This study will determine whether the medication metoclopramide can improve red blood counts
in people who have myelodysplastic syndrome (MDS). MDS is thought to affect blood stem
cells, which can result in low levels of red blood cells-that is, anemia-as well as low
white blood cell and platelet counts. Patients with MDS are at risk for infection,
spontaneous bleeding, and possible progression to leukemia, a cancer of bone marrow.
Although bone marrow can produce some blood cells, this production can be decreased in
patients with MDS. The definitive way to treat MDS is stem cell transplantation, but serious
complications and a high risk of death make it unsuitable for patients older than age 60 or
those who do not have a matched sibling donor. However, scientists have noted improvement in
anemia by using metoclopramide, an inexpensive, commonly used medication that does not have
many negative side effects. This study will evaluate the safety and effectiveness of that
medicine for patients with MDS.
Patients ages 18 to 72 whose MDS would require low-intensity treatment-for example, with
growth factor and transfusions-and who are not pregnant or breastfeeding may be eligible for
this study. There will be about 60 participants.
Screening tests include a complete physical examination and medical history, during which
patients will provide a list of current medications or supplements they are taking. There
will be a collection of about 4 tablespoons of blood for analysis of blood counts as well as
liver and kidney function. Patients may also undergo a magnetic resonance imaging (MRI) scan
of their brain, but the procedure is optional. During the MRI, they will lie on a table that
will slide into the enclosed tunnel of the scanner. The MRI takes about 20 to 30 minutes,
and patients will be asked to lie as still as possible. There will also be a bone marrow
biopsy, if patients have not had one done within 4 weeks of the start of this study.
Eligible patients will take a 10 mg dose of metoclopramide by mouth, three times a day, for
20 weeks. They will be given a 4-week supply, which will be renewed monthly at each
treatment visit. It is essential that patients be seen at NIH during the first, third, and
fifth months of the study. Visits made in the meantime, at the second and fourth months, may
be done at the office of their doctors who have referred them for the study, or at NIH.
During the treatment visits, patients will be asked to update their medical history, health
conditions, and use of medications or herbal supplements. There will also be a collection of
about 1 tablespoon of blood for laboratory tests. Patients will be asked to make a similar
follow-up visit 1 month after they stop taking metoclopramide, so that the response to
treatment can be evaluated.
The use of metoclopramide may cause some people to feel dizzy, lightheaded, tired, or less
alert than they are normally. For the first 24 to 48 hours, patients should be cautious when
driving, using machinery, or performing hazardous activities. This medicine will add to the
effects of alcohol and other central nervous system depressants-such as medicines for
allergies and colds, tranquilizers, and prescription pain relievers. Patients need to check
with the research team before taking any of those types of medicines, as well as herbal
supplements, while using metoclopramide.
This study may or may not have a direct benefit for participants. For some, the drug may
improve red blood cell counts and decrease the need for red cell transfusions. Knowledge
gained in the study may help people in the future.

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